Determining The Effect of Tele-Nursing on Caregiver Burden in Family Caregivers and Self-Efficacy in Patients With COVID-19
Design
This is a randomized clinical trial study that will be performed on 60 patients with covid-19 and patient caregivers.
Settings and conduct
Using easily available sampling, we sample all patients with covid-19 and their family caregivers who have been admitted and discharged in hospitals affiliated to Sabzevar University of Medical Sciences. Samples are randomly divided into experimental and control groups based on permutation blocks. demographic characteristic questionnaire, Caregiver Burden and self-efficacy before and after one month of intervention online To be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Lack of Clear Mental and Cognitive Impairment and Severe Mood-Emotional Disorder
Patients in Live in House Quarantine
Failure To Participate in The Empowerment Program
Have a Diagnosis of Covid-19 (positive PCR test)
Having a home phone or cell phone
Be careful
Exclusion criteria: The Patient's Unwillingness To Participate in The Study
Intervention groups
In the Intervention Group, a 2-3 Hour Training Session is Held Under The Title of one-day Training Workshop Through Multimedia Software (Audio, Video, Image) and Related Platforms Including WhatsApp, Imo and Telegram, for Patients and Caregivers of the Same Patients. After That, in the Intervention group, Telephone Follow-up for one Month Will Be Done Daily in the First Two Weeks and Two Days in the Second Two Weeks.
For the control group, only routine hospital care.
Main outcome variables
Caregiver Burden in Family Caregivers and Self-Efficacy in Patients With COVID-19
General information
Reason for update
Acronym
Covid-19
IRCT registration information
IRCT registration number:IRCT20210111050011N1
Registration date:2021-02-16, 1399/11/28
Registration timing:prospective
Last update:2021-02-16, 1399/11/28
Update count:0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Ahmad Rajab Dizavandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3212 7476
Email address
ahmad.r.dizavandi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-09, 1400/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Tele-Nursing on Caregiver Burden in Family Caregivers and Self-Efficacy in Patients With Covid-19 After Discharge From Hospitals
Public title
The Effect of Tele-Nursing on Caregiver Burden in Family Caregivers and Self-Efficacy in Patients With Covid-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study
Age Over 30 Years and Maximum 60 Years
No Hearing Or Vision Disorders (Deaf And Dumb)
Lack of Clear Mental and Cognitive Impairment and Severe Mood-Emotional Disorder That Prevents Effective Communication
No Event Or a Stressful Event in The Last 6 Months for the Patient
Speak Persian or Understand Persian (Or Have a Companion Who Dominate in Persian)
Be Able To Read or Write (Or Have a Companion Him Literacy For Reading and Writing)
Patients living with Family
Patients in Live in House Quarantine
Failure To Participate in The Empowerment Program
Have a Diagnosis of Covid-19 (positive PCR test)
Having a Home Phone or Cell Phone
Be Careful
Have Experienced the Same Conditions for Covid-19 Disease.
Exclusion criteria:
The Patient's Unwillingness To Participate in The Study
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available methods and will be randomly assigned to intervention and control groups using random allocation blocks. R Software will be used to get the blocks. The blocks are made up of 4 English letters (A,B,C,D). A , and B will be considered for the intervention group, and other two letters (C, and D) will be considered for the control group. The blocks will be randomly selected in blindfolded manner. Each block will determine the order of entry in the intervention and control groups. Assuming choosing the DABC block means from left hand, first, and fourth, respectively, will be located in the control group, and the second, and third of participants will be located in the intervention group, respectively. Thus, fifteen blocks will be selected to complete the sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single blind and only the participant and the statistical consultant are not aware that the participant is in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Sabzevar University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs, Blvd of Nuclear Martyrs
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.MEDSAB.REC.1399.174
Health conditions studied
1
Description of health condition studied
Coronavirus Disease (COVID-19)
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Caregiver Burden in Family Caregivers'
Timepoint
Before and After one Month of Intervention
Method of measurement
Novak and Guest Caregiver Burden Questionnaire (1989)
2
Description
Self-Efficacy of Patients With Covid-19
Timepoint
Before and After one Month of Intervention
Method of measurement
Prevention, Recognition and Home-Management Self-Efficacy Scale (COVID-19-SES)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the Intervention Group, a 2-3 Hour Training Session is Held Under The Title of one-day Training Workshop Through Multimedia Software (Audio, Video, Image) and Related Platforms Including WhatsApp, Imo and Telegram, for Patients and Caregivers of the Same Patients. And training on the disease and ways to prevent its transmission, attention to quarantine time, location (features of the quarantine room, disinfection of the quarantine room, patient areas such as bathrooms and toilets), social communication, diet and medication In quarantine, psychological issues (psychological strategies for stress management), having a healthy lifestyle, sleeping and resting in quarantine, management of outpatient care (weakness and lethargy, fever and body aches, loss of sense of smell, nausea and vomiting, diarrhea, Ventilation, adequate nutrition, adequate fluids, providing minimum facilities for psychosocial support) are provided to the patient and caregiver. After That, in the Intervention group, Telephone Follow-up Will Be Done Daily for one Month in the First Two Weeks and Two Days in the Second Two Weeks. An Agreement is Reached Regarding Follow-up Times and Calls, and The Contact Number of The Researcher and WhatsApp, Imo, Telegram and SMS Media are Provided to the Participants so that They can Communicate and Ask their Questions Whenever Necessary. Depending on the Condition of the Caregiver and the Patient, and Depending on Which Stage of The Disease the Patient is in, There is Training and Related Care Appropriate to that Stage of the Disease, and If Necessary, the Patient is Referred to an Infectious Disease Specialist. Remote Nursing Recommendations are also Given to Prevent Infection Transmission, Patient Recovery, and Outpatient Problems.
Category
Rehabilitation
2
Description
Control group: Only Routine Hospital Care Will be Provided. The ward Nurse Provides The Necessary Training Related to Infection Control, Medication Use, Go to The Hospital If The Patient's Condition Worsens and Visit Again.
Vice Chancellor for Research and Technology, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs, Boulevard of Nuclear Martyrs
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112- 96179131
Phone
+98 51 4401 8101
Fax
+98 51 4401 8102
Email
vc.Research@medsab.ac.ir
Web page address
http://vcresearch.medsab.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ahmad Rajab Dizavandi
Position
Master Student of Internal Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs, Blvd of Nuclear Martyrs
City
Sabzevar
Province
Razavi Khorasan
Postal code
9157863346
Phone
+98 51 3212 7476
Email
ahmad.r.dizavandi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs, Blvd of Nuclear Martyrs
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8308
Email
mostafarad633@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ahmad Rajab Dizavandi
Position
Master Student of Internal Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs, Blvd of Nuclear Martyrs
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 3212 7476
Email
ahmad.r.dizavandi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
For More Security of Participants' Data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available